i guess one can construe indirect, clear and convincing evidence of intent to deceive the PTO to get a false patent issued

"YEDA and, on information and belief, TEVA’s assertions to the PTO regarding the higher toxicity of higher molecular weight copolymer-1 compositions were so directly contradictory to their statements to the FDA and the assertions made in the Bornstein et al. paper that the contradiction cannot reasonably be interpreted as an error, but instead as an intentional effort to deceive the PTO."

The Summary Basis of Approval for TEVA’s NDA reveals that TEVA, working with YEDA, conducted numerous studies showing that copolymer-1 compositions having an average molecular weight from 4.7 kDa to 13.0 kDa did not produce a statistically significant toxic effect in rats and humans. These studies reported that copolymer-1 compositions with a molecular weight above 10 kDa were not toxic to animals or humans. See Review and Evaluation of Pharmacology Toxicology Data from Teva’s NDA #20-622, undated, and Review and Evaluation of Clinical Data: Safety, from Teva’s NDA #20-622, dated January 30, 1996, Appendix 7.b.1 and 7.b.2

YEDA and, on information and belief, TEVA also made material omissions by failing to highlight adequately the significance of the Johnson et al. and Bornstein et al. papers to the PTO. This is evidenced, as just one example, by YEDA and, on information and belief, TEVA’s failure to cite the Johnson et al. and Bornstein et al. papers as references for the ’430 patent, the application for which was filed on February 27, 1998. Similarly, YEDA and, on information and belief, TEVA failed to cite those papers as references for the ’847 patent, the application for which was filed on December 14, 2001. The Bornstein et al. and Johnson et al. papers were finally cited as references for the ’539 patent, the application for which was filed on July 10, 2003. However, the two papers are listed near the end of nearly three pages of references and their titles were not included in the listing. Both listings contained errors: the journal for the Johnson et al. paper was listed as Neurobiology rather than Neurology, and the Bornstein et al. paper was listed as authored by “Borenstein.”

The results presented by TEVA and YEDA to the FDA, that higher molecular weight (i.e., 10.0 to 13.0 kDa) copolymer-1 compositions are not toxic, or no more toxic than lower molecular weight copolymer-1 compositions (4.7 to 10.0 kDa), were consistent with a paper published in the New England Journal of Medicine and co-authored by three individuals— Ruth Arnon, Michael Sela, and Dvora Teitelbaum—listed on the four patents asserted by Plaintiffs in the current case. In that paper, Murray B. Bornstein et al., A Pilot Trial of Cop-1 in Exacerbating-Remitting Multiple Sclerosis, 317 New Eng.J. Med. 408 (1987), the authors reported that copolymer-1, with a molecular weight between 14 and 23 kDa (unspecified metric), was well tolerated by patients, showing that copolymer-1 compositions with an average molecular weight above 10 kDa were not toxic to humans. Bornstein et al. also reported that administration of 14-23 kDa copolymer-1 was non-toxic during short-term and long-term administration in mice, rabbits, and dogs.

In order to avoid certain prior art objections and to obtain its patents, YEDA and, on information and belief, TEVA intentionally made false representations to the PTO regarding the toxicity of copolymer-1 compositions. The false representations were directly contrary to TEVA and YEDA’s own findings in its clinical trials, contradicted what TEVA and YEDA had told the FDA, and were contrary to the published research findings of three of the listed individuals on TEVA and YEDA’s patents.